Let’s get you up to speed: the Patent and Trademark Office doesn’t grant patents over actual genes in the human body, but does award patents for genetic sequences that have been identified by researchers. Patents also extend to genetic tests and to correlations that scientists have drawn between genetic sequences and medical conditions, such as hearing loss, Alzheimer’s disease and cancer.

But should such gene sequences be patentable? Many doctors, patients and academics say no, that they’re the products of nature and should never give rise to property rights. Gene patents, they say, create monopolies, allowing patent holders to block alternative tests and research that might ultimately yield better, and cheaper, medical care.

Defenders of gene patents do what good lawyers do, draw analogies. “Gene patents are no different than patents granted to antibiotics extracted from fungus or to adrenaline purified from cow tissue,” says Hans Sauer, associate general counsel for the Biotechnology Industry Organization.

Now, a case pending in New York federal court is the first to squarely address whether genetic sequences can be patented. The suit concerns patents covering the so-called BRCA 1 and 2 genes, which have been linked to an increased risk of breast and ovarian cancers.
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The plaintiffs, who include doctors and women diagnosed with breast cancer, claim Utah-based Myriad Genetics, which owns various BRCA patents and sells BRCA screening tests, has the power to block alternative tests and research.

“It is unconstitutional that our patent office granted a patent on a part of the body,” says plaintiff Genae Girard. After being diagnosed with breast cancer, the 40-year-old Austin, Texas, resident underwent a Myriad test in 2006 indicating she had a BRCA2 gene mutation. Girard says she was upset to learn that an alternative BRCA test wasn’t available.

Myriad’s BRCA patents have enabled the company to develop pioneering genetic tests and to hire a large sales force, which has helped make the test widely accessible and affordable to patients, says Richard Marsh, Myriad’s general counsel. “Myriad is a poster child for the success of the patent system,” he says. “We spent hundreds of millions of dollars and 12 years on BRCA research and other expenses before we recouped our initial investment.”

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The Law Blog covers the legal arena’s hot cases, emerging trends and big personalities. It’s brought to you by lead writer Jacob Gershman with contributions from across The Wall Street Journal’s staff. Jacob comes here after more than half a decade covering the bare-knuckle politics of New York State. His inside-the-room reporting left him steeped in legal and regulatory issues that continue to grab headlines.

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